Polaris

SOP# MON-009.0CompanyEffective Date: DD/MMM/YYICH Guidelines for Good Clinical Practice (E6) section 4.4 – Communication withIRB/IECICH Guidelines for Good Clinical Practice (E6) section 5.9 – FinancingICH Guidelines for Good Clinical Practice (E6) section 5.11 – Confirmation of Reviewby IRB/IECICH Guidelines for Good Clinical Practice (E6) section 5.12 – Information onInvestigational ProductsICH Guidelines for Good Clinical Practice (E6) section 5.14 – Supplying and HandlingInvestigational Product(s)ICH Guidelines for Good Clinical Practice (E6) section 5.15 – Record AccessICH Guidelines for Good Clinical Practice (E6) section 5.21 – Premature Termination orSuspension of a TrialFDA Information Sheets – Record Keeping in Clinical Investigations, October 1995V. AttachmentsAttachment A – IRB Study Termination Notification FormAttachment B – Screening and Enrollment LogAttachment C – Study Responsibilities FormAttachment D – Signature SheetMON-009.0.doc© 2004 by CRC Press LLC